Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT00816465
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2009-05-31
2010-08-31
Brief Summary
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Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes.
Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Patients receiving Hoodia
Hoodia gordonii
PO administration of 1 Tab Hoodia gordoni extract per day.
2
Patients receiving placebo
Placebo
PO Placebo pill
Interventions
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Hoodia gordonii
PO administration of 1 Tab Hoodia gordoni extract per day.
Placebo
PO Placebo pill
Eligibility Criteria
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Inclusion Criteria
* Men and women age 18 to 65 years inclusive.
* Patients with biopsy proven NASH with a score of 4 or above.
* Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance.
* HBA1C between 5.5 and 14%.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Yotvata - Hoodia Growers in the Arava
Locations
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Hadassah Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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HoodiaNAFLD-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id